Devices › Analyzer, gas, carbon-dioxide, gaseous-phase
Device brand name · Multi-gas unit
Gf-210ra: medical device reports filed with FDA
290 reports name it, 2014–2024. Manufacturer given most often on reports: Nihon Kohden. Product code CCK.
- 290
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.7%
- classified as malfunction
- 98.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 290 reports that name the brand "Gf-210ra" (multi-gas unit), received between December 2014 and February 2024; the manufacturer given most often on reports is Nihon Kohden. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (99.7%) and other (0.3%); across all analyzer, gas, carbon-dioxide, gaseous-phase reports (product code CCK) death is recorded in 0.3% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are output problem (59.3%), no device output (10.3%) and unable to obtain readings (8.6%). FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 12,829 reports carrying product code CCK. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Output problem | 172 | 59.3% | 2.4% |
| No device output | 30 | 10.3% | 4.4% |
| Unable to obtain readings | 25 | 8.6% | 1.3% |
| Incorrect, inadequate or imprecise result or readings | 20 | 6.9% | 6.1% |
| Device stops intermittentlythe device stopped now and then | 15 | 5.2% | 0.2% |
| Application program problem | 14 | 4.8% | 0.2% |
| Device displays incorrect message | 13 | 4.5% | 0.7% |
| Device inoperablethe device could not be used | 11 | 3.8% | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 3.4% | 0.7% |
| Device sensing problem | 9 | 3.1% | 1.4% |
| Gas output problem | 9 | 3.1% | 0.4% |
| Image display error/artifact | 9 | 3.1% | 0.4% |
| Display or visual feedback problem | 6 | 2.1% | 0.9% |
| Erratic or intermittent display | 6 | 2.1% | 0.1% |
| Failure to sense | 6 | 2.1% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 4 | 1.4% | 26.8% |
| Electrical power problem | 4 | 1.4% | 0% |
| Incorrect measurementthe device measured wrongly | 4 | 1.4% | 0.7% |
| Data problem | 3 | 1% | 0.1% |
| Device issuea problem with the device | 3 | 1% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
In context
| Measure | Gf-210ra | Product code CCK | All MAUDE reports |
|---|---|---|---|
| Reports | 290 | 12,829 | 26,136,888 |
| Share of that pool | — | 2.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 0% | 1% | 36.2% |
| Classified as malfunction | 99.7% | 98.5% | 62.3% |
| Filed by the manufacturer | 81.4% | 97.7% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code CCK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Alaris System | 422,501 | 33,692 | 0% |
| 8300 Alaris Etco2 Module | 3,365 | 0 | 0% |
| Alaris Etco2 | 259 | 0 | 0% |
| Alaris Etco2 Module | 573 | 0 | 0.2% |
| Gf-210r | 171 | 95 | 0% |
| Ag-920ra | 152 | 0 | 0% |
| Nellcor | 1,814 | 215 | 3.9% |
| Versaport Plus | 195 | 5 | 1% |
| Alaris | 1,229 | 79 | 1.1% |
| Covidien | 422 | 30 | 1.4% |
| Philips | 190 | 0 | 6.3% |
| 8100 Alaris Pump Module | 163,620 | 0 | 0% |
| 8120 Alaris Pca | 6,258 | 0 | 0% |
| AirLife | 155 | 37 | 2.6% |
| Alaris Pca | 1,707 | 0 | 0.1% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Gf-210ra reports
How many FDA reports name Gf-210ra?
290 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (99.7%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
output problem (59.3%), no device output (10.3%), unable to obtain readings (8.6%), incorrect, inadequate or imprecise result or readings (6.9%) and device stops intermittently (5.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (81.4%) and distributor reports (18.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Gf-210ra was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.